New Risk Assessment Paradigm to Predict Screening Detection, Failures and False Alarms

新的风险评估范式可预测筛查检测、故障和误报

基本信息

批准号：
9279002
负责人：
KARLA M KERLIKOWSKE
金额：
$ 29.69万
依托单位：
UNIVERSITY OF CALIFORNIA AT DAVIS
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-01 至 2022-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9279002
关键词：
Advisory Committees Age American Cancer Society Benign Biopsy Breast Cancer Detection Breast Cancer Risk Factor Breast Cancer Surveillance Consortium Cancer Biology Cessation of life Clinical Clinical/Radiologic Community Practice Community of Practice Consensus Data Decision Making Detection Digital Breast Tomosynthesis Digital Mammography Disease Early Diagnosis Effectiveness Ethnic Origin Failure Frequencies General Population Goals Guidelines Harm Reduction Health Personnel Heterogeneity High Risk Woman Incidence Individual Life Malignant Neoplasms Mammography Masks Modality Modeling Movement Noninfiltrating Intraductal Carcinoma Outcome Output Population Preventive service Primary Health Care Provider Race Radiation exposure Radiation-Induced Cancer Recommendation Regimen Research Infrastructure Research Personnel Risk Risk Assessment Risk Estimate Risk Factors Statistical Methods Subgroup Surveys Testing Woman Women&apos s Health advanced disease aged base breast density cancer invasiveness cancer risk clinical imaging clinical practice clinically actionable comparative effectiveness compare effectiveness cost digital discrete time experience high risk improved innovation lifetime risk malignant breast neoplasm models and simulation mortality novel personalized decision predictive modeling preference radiologist screening secondary outcome tomosynthesis tumor

项目摘要

PROJECT SUMMARY – Project 1 The 2016 US Preventive Services Task Force and 2015 American Cancer Society guidelines call for reduced screening intensity and for providers to discuss with women their preferences for screening. This push for individualized decision-making has triggered substantial movement toward risk-based screening utilization that does not rely solely on a woman's age to determine when to start and stop screening or screening frequency. Yet, the explicit incorporation of risk assessment into screening guidelines for the general population is in its early stages. Risk prediction is a key aspect of risk-based screening; available models predict breast cancer risk overall, but do not take into account the heterogeneity of breast cancer biology or the ability of screening modalities to detect breast cancer. Project 1 aims to advance a new risk-based screening paradigm that identifies women's absolute cumulative risk of screening detection, failures, and false alarms while explicitly considering screening interval and modality used. Aim 1) Using the existing and expanded Breast Cancer Surveillance Consortium (BCSC) infrastructure, project investigators will develop new risk prediction models to identify women at high risk of: 1) early-stage screen-detected cancer (stage I/IIa invasive cancer), 2) screening failure (interval invasive cancer or screen-detected stage IIb or higher), and 3) false alarms (false-positive tests and benign biopsies). Using BCSC data on over 1,000,000 women aged 40-79 years undergoing digital mammography or tomosynthesis, and over 13,000 invasive breast cancers identified, the project team will identify clinical and imaging factors associated with breast cancer risk that impact screening outcomes, generating six-year risk estimates for each screening outcome for annual, biennial, and triennial screening regimens. Aim 2) The project team will identify actionable levels of clinically-meaningful risk of screening failure and false alarm, and associated long-term screening outcomes using women and clinician surveys and Delphi panels. This proposal will answer: 1) Which women are at high risk of screening failures and require an alternative strategy to biennial mammography, and which women are at low risk and can be screened less often? 2) What risk levels of poor screening outcomes impact women and clinician preferences for screening strategies? This project will provide evidence to guide women, health care providers, and policymakers on screening strategies based on short-term risk of screening failures and false alarms with the goal to improve early detection of aggressive tumors while minimizing harms.

项目摘要 – 项目 1 2016 年美国预防服务工作组和 2015 年美国癌症协会指南呼吁降低筛查强度，并要求医疗服务提供者与女性讨论她们对筛查的偏好。这种对个性化决策的推动引发了基于风险的筛查利用的重大变革。仅依靠女性的年龄来确定何时开始和停止筛查或筛查频率。然而，将风险评估明确纳入一般人群的筛查指南尚处于早期阶段。可用型号；总体预测乳腺癌风险，但不考虑乳腺癌生物学的异质性或检测乳腺癌的筛查方式的能力。项目 1 旨在推进一种新的基于风险的筛查范式，确定女性筛查检测的绝对累积风险。、故障和误报，同时明确考虑筛查间隔和使用的方式。目标 1) 利用现有和扩大的乳腺癌监测联盟 (BCSC) 基础设施，项目研究人员将开发新的风险预测模型，以识别处于以下高风险的女性：1) 早期筛查检测到的癌症（I/IIa 期浸润性癌症） , 2) 筛查失败（间期浸润性癌症或筛查检测到的 IIb 期或更高阶段），以及 3) 错误警报（假阳性检测和良性活检）。 1,000,000 名 40-79 岁的女性接受数字化乳房 X 光检查或断层合成，并确定了超过 13,000 例浸润性乳腺癌，项目团队将确定与影响筛查结果的乳腺癌风险相关的临床和生成因素，对每次筛查结果进行六年风险估计每年、每两年和每三年一次的筛查方案。目标 2) 项目团队将利用女性和临床医生调查以及德尔菲小组，确定筛查失败和误报的具有临床意义的风险的可操作水平，以及相关的长期筛查结果。该提案将回答： 1) 哪些女性筛查失败的风险较高，需要采取两年一次乳房 X 光检查的替代策略，哪些女性风险较低，可以减少筛查频率 2) 不良筛查结果对女性的影响有多大？以及临床医生对筛查策略的偏好？该项目将提供证据，指导妇女、医疗保健提供者和政策制定者根据筛查失败和误报的短期风险制定筛查策略，目标是改善侵袭性肿瘤的早期发现，同时最大程度地减少伤害。